ELECTRONIC BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

SHENZHEN URION TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Shenzhen Urion Technology Co., Ltd. with the FDA for Electronic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK141683
510k NumberK141683
Device Name:ELECTRONIC BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant SHENZHEN URION TECHNOLOGY CO., LTD. 4TH BUILDING, HI-TECH INDUSTRIAL ZONE, HEPING COMMUNITY, FUYONG STREET, BAOAN DISTRICT Shenzhen,  CN 518103
ContactAutumn Liu
CorrespondentAutumn Liu
SHENZHEN URION TECHNOLOGY CO., LTD. 4TH BUILDING, HI-TECH INDUSTRIAL ZONE, HEPING COMMUNITY, FUYONG STREET, BAOAN DISTRICT Shenzhen,  CN 518103
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-23
Decision Date2015-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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